Improving Post Discharge Care After Acute Kidney Injury (AFTER AKI)
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| ClinicalTrials.gov Identifier: NCT02915575 |
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Recruitment Status :
Recruiting
First Posted : September 27, 2016
Last Update Posted : January 31, 2023
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| Tracking Information | |||||||||
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| First Submitted Date ICMJE | September 22, 2016 | ||||||||
| First Posted Date ICMJE | September 27, 2016 | ||||||||
| Last Update Posted Date | January 31, 2023 | ||||||||
| Actual Study Start Date ICMJE | March 19, 2018 | ||||||||
| Estimated Primary Completion Date | December 31, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Proportion of patients develop Chronic kidney disease after Acute kidney injury [ Time Frame: 90 days ] The primary (process based) outcome of this trial is the proportion of patients with CKD meeting all three quality of care indicators (statin use, ACEi/ARB use in those with proteinuria (ACR>30mg/mmol) or diabetes, nephrologist visit if sustained eGFR<30ml/min/1.73m2) within 90 days of hospital
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Improving Post Discharge Care After Acute Kidney Injury | ||||||||
| Official Title ICMJE | Advancing Community Care and Access to Follow-up After Acute Kidney Injury Hospitalization | ||||||||
| Brief Summary | The purpose of this trial is to test the clinical benefit and feasibility of structured risk based post discharge care for hospital acquired Acute kidney injury survivors.This is a Pragmatic randomized controlled trial. It will be conducted at 2 hospitals in Alberta. 166 participants will be enrolled in this Randomized controlled trial.. | ||||||||
| Detailed Description | Research Objective: To evaluate the impact of risk based decision support on processes of care for high-risk patients following discharge after hospitalization with Acute Kidney injury. Experimental Strategy- rationale and considerations: International guidelines for Chronic Kidney disease diagnosis and management provide a stage-based management approach to reduce the risk of adverse cardiovascular and renal outcomes based on estimated glomerular filtration rate (eGFR) and proteinuria. Identified key quality indicators for CKD care include the use of statins in CKD patients greater than age 50, or with diabetes or cardiovascular disease, use of ACEi (angiotensin-converting enzyme inhibitor) and ARB (angiotensin receptor blocker) in patients with proteinuria and referral to nephrology care with a sustained eGFR <30/ml/min/1.73m2. patients at low risk of CKD can be effectively managed by primary care given appropriate support. Study investigator will evaluate the identification of CKD by providing lab requisitions to all study participants. Those in the medium and high risk groups for CKD based on our risk index will be further guided to either a primary care web-based CKD care pathway which helps Primary care Physicians identify, treat and refer CKD patients using best practices, or nephrology care, respectively. Transitional care interventions have been shown to be effective preventing readmission in chronic conditions such as heart failure. Specialist care delivery often through multidisciplinary clinics has been found to improve prescription of proven efficacious medications and outcomes in a number of chronic disease settings including heart failure, Myocardial infarction,asthma and CKD. As there is no specific intervention for treating Acute kidney injury ensuring high adherence to CKD care in affected individuals is a feasible, sustainable strategy. Participants The trial population will be comprised of consenting adult patients admitted to general medical or surgical teaching wards at 2 centers, the University of Alberta Hospital in Edmonton and the Foothills Hospital in Calgary. Randomization Participants will be randomized to either Control arm or Experimental arm Control arm (Usual Care): Participants will be discharged as per usual ward discharge protocols. A requisition for follow-up labs (serum creatinine, serum electrolytes, urine albumin/creatinine ratio) to be drawn at 90 days will be given to each participant. Appointments/referrals will be left at the discretion of the care team. Experimental arm (Risk Guided Follow-up): Participants will be stratified for risk of CKD into three groups: low (<1% risk of CKD), medium (1-10 % risk of CKD) and high (≥10 % risk of CKD) using a risk index developed by the team. Specific follow-up will be guided by risk status. Analysis Plan: The primary analysis will follow an intention-to-treat approach. In sensitivity analyses, outcomes based on the predicted risk of CKD will be stratified. Descriptive statistics and bivariate tests of associations will be used as appropriate to evaluate group differences at various time points of follow-up. Associations between key variables and study outcomes will be analyzed using appropriate univariate, multivariate and mixed model multilevel analyses. No interim analyses are planned due to the short duration of the trial. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Acute Kidney Injury | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
166 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | December 31, 2023 | ||||||||
| Estimated Primary Completion Date | December 31, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Canada | ||||||||
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| Administrative Information | |||||||||
| NCT Number ICMJE | NCT02915575 | ||||||||
| Other Study ID Numbers ICMJE | Pro00067815 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Current Responsible Party | University of Alberta | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor ICMJE | University of Alberta | ||||||||
| Original Study Sponsor ICMJE | Same as current | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | University of Alberta | ||||||||
| Verification Date | January 2023 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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